Discontinuation vs. continuation of concomitant methotrexate in patients with rheumatoid arthritis on certolizumab pegol: results from a randomised, controlled trial
Primary result · Maintained LDAResult — go to the resultDifference - 1.6% 90% CI −14.6 to 11.3%Authors' conclusion
Discontinuing concomitant MTX in RA patients on CZP is clinically feasible for maintaining LDA.
Study context
- Population
- Rheumatoid arthritis (RA) patients with sustained low disease activity (LDA) (CDAI ≤ 10) for ≥ 12 weeks on certolizumab pegol (CZP) + methotrexate (MTX)all included in efficacy analysis
- Participants
- 84 patients
- Comparison
- Discontinuing MTX after a 12-week reduction period vs continuing MTX, alongside CZP
- CZP + MTXn = 41reference
- CZPn = 43
- Primary endpoint
- Proportion maintaining LDA without a flare (CDAI > 10 or rescue treatment for any reason)
- Follow-up
- Week 36 (24 weeks after MTX discontinuation)
Methodological detailsnon-inferiority, multicentre, open-label, computer randomisation 1:1 by minimisation
- Non-inferiority
- Multicentre
- Open-label
- Computer randomisation 1:1 by minimisation
Primary result
Maintained LDA · week 36
Difference
- 1.6%
90% CI −14.6 to 11.3%
By group
CZPvs CZP + MTX
difference - 1.6% (90% CI −14.6 to 11.3%)
As reported in the abstract
Safety
Gastrointestinal symptoms (self-administered questionnaire) · week 36 · significantly lower in the CZP group
P = 0.034
Reported adverse events
- Broadly similar between the two groups
Original publication
Discontinuation vs. continuation of concomitant methotrexate in patients with rheumatoid arthritis on certolizumab pegol: results from a randomised, controlled trial. Arthritis Res Ther. Published 5 April 2025. doi:10.
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